Central Part of the ISO 13485 Quality System

May 14, 2020May 14, 2020

The management’s responsibility is to appoint a person of authority that will communicate the quality policy and expectations of top management to the medical device company and to receive feedback regarding the status and performance of the Quality Management System.

The representative

The representative must not be a quality manager, even though it is common, they should be a member of top management and have the authority to decide. Check the following considerations for representative:

Interrelations and applications between the representative and the quality manager should be defined when the management representative isn’t the quality manager

External responsible body in which top management has confidence can be representative

It is recommended, for personnel chosen to be representative, to have the appropriate background and knowledge relevant to the technologies, area, and nature of the medical devices

Ensure that there are no conflicts arise due to obligation to the quality management system if the representative is involved in more activities in the organization

For determining the representative, there are a lot of possibilities, but the issue must be documented.If the representative has another role in MedDev company, that fact should be documented on their job description. The company should produce some sort of documentation to define responsibilities to the top management and the organization if the representative is an external party.

Examining and reporting

The goals of the representative are the following:

Inform of need for improvements

Ensure that quality objectives are achieved

Ensure that the required processes are established and maintained according to the specifications

The main responsibility of the representative is to observe and evaluate the status of the Quality Management System. The representative also has to report to the top management whether the main objectives of the QMS is accomplished and of the status of developments. The observation will be done through the estimation of the processes that were identified as relevant to the QMS and were defined in the quality manual. Regarding the reporting methods or intervals, there isn’t an exact requirement. They can be developed as management reviews, as internal audit reports or as complaints reports.

The reporting can change according to different activities and areas. The reporting requirements, methods, and intervals must be defined and documented in the appropriate documentation.

Promotion of Awareness

Promoting the awareness of the employees of regulatory and customers’ requirements is one of the roles of the management representative. It is intended for management representatives to define the topics and issues that are applicable to the requirements, customers’ and regulatory. The requirements of customers and regulations should be identified on each level of a medical device company, expressed and verified, that measures to promote awareness are being taken. The ways to promote the issues should be planned according to the activities of the organization: training, lectures, publications, certifications, etc.

Join the discussion

I like this article. I just wondered, if there is any specific process for evaluation of QMS status? is it just like a report, or there is a specific document for it that you have to fill up? Or it’s just up to the company?